Lewis Yasenchak
Recent Articles
ISO 13485:2016 certification in 6 steps
Where does your company stand? Learn more about the six main steps to ISO certification. Next, fill out the free business assessment questionnaire to see where to start for ISO implementation, certification.
6 steps to ISO 13485:2016 certification
Learn more about the six steps to certification and then fill out the free business assessment questionnaire to see where your company stands and where to start for ISO implementation and certification.
ISO 13485:2016 requires leadership, assistance
The final edition of this 3-part series looking at changes between ISO 13845:2003 and ISO 13485:2016 covers the need for leadership and how building partnerships with suppliers adds value to a company and its quality management system.
ISO urges value stream mapping
In Part 2 of this 3-part series on the changes between ISO 13845:2003 and ISO 13485:2016, P&Y Management Resources’ founder discusses how to quantify the cost of quality.
Compliance simplified in revised ISO 13485:2016
This is the first part of a three-part series focused on the changes between ISO 13845:2003 and ISO 13485:2016. The second and third parts of this series will be featured in upcoming issues of Today’s Medical Developments.